BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS X

    MDR report key: 1269736 · Received December 17, 2008

    Report

    Report Number
    2953184-2008-00074
    Event Type
    Injury
    Date Received
    December 17, 2008
    Date of Event
    February 6, 2007
    Report Date
    November 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC, EP TECHNOLOGIES, INC
    Product Code
    MTD
    PMA / PMN Number
    K940168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO PERFORM A PRODUCT ANALYSIS AS NO DEVICE WAS RECEIVED. THERE IS NO EVIDENCE THAT INDICATES THE DEVICE INVOLVED IN THIS EVENT MALFUNCTIONED, OR IN SOME WAY DID NOT PERFORM TO SPECIFICATION THAT MAY HAVE RESULTED IN THIS EFFECT. THE REPORTED EVENT IS A KNOWN/POSSIBLE PROCEDURAL COMPLICATION AND IS APPROPRIATELY LABELED AS AN ADVERSE EVENT WITHIN THE DIRECTIONS FOR USE. WE WERE UNABLE TO REVIEW MANUFACTURING RECORDS AS THE BATCH NUMBER IS UNKNOWN. A SIMILAR COMPLAINT TREND WAS REVIEWED FOR THIS PRODUCT FAMILY, AND NO ADVERSE TRENDS WERE IDENTIFIED.

    Description of Event or Problem · 1

    DURING A REVIEW OF INFO RELATED TO THE CRYOCOR CLINICAL TRIAL, WE DISCOVERED THAT THE PATIENT EXPERIENCED SICK SINUS SYNDROME POST-PROCEDURE THAT REQUIRED HOSPITALIZATION FOR IMPLANTATION OF PERMANENT PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS X STEERABLE DECAPLOAR MAPPING CATHETER MTD BOSTON SCIENTIFIC, EP TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R